mHealth Regulatory Coalition draft document posted

Donna Cusano

The mHealth Regulatory Coalition–an ad hoc group formed to recommend what FDA should and should not regulate in mHealth systems [TA 29 Dec and prior]–has just published for review Part One of a three-part guidance document creating a framework to address the risk model and intended use claims. Is a device intended or not intended for a medical purpose? FDA cannot regulate if the answer is no. They are eagerly inviting comments on the 12-page draft document (direct link here); comments (after you read it, of course) to Bradley Merrill Thompson at Epstein, Becker.